"The international system for the development, production and distribution of pharmaceutical products faces enormous challenges, but the nature of the challenges is not universal," Abbott said.

FSU News

World experts on pharmaceuticals to tackle regional priorities for delivering medicines globally

by Barbara Ash

The Florida State University College of Law is gathering together 30 of the world's most creative thinkers and leading experts on pharmaceuticals this week to discuss the future of global pharmaceutical regulation, ways to improve the system, research and development for new pharmaceuticals, and assuring access to medicines.

Participants in the roundtable "Global Pharmaceutical Regulation 2007: Tackling Regional Priorities" will include, among others, representatives from the World Health Organization, the World Bank, Médecins San Frontières, the Indian Pharmaceutical Alliance, the Latin American Association of Pharmaceutical Industries, the Consumer Project on Technology, the Federal Trade Commission and the National Institutes of Health. The roundtable will take place April 5-7.

The event is being organized by Fred Abbott, the Edward Ball Eminent Scholar Professor of International Law at FSU. He is acknowledged as a leading figure in world public health and has been highly effective in helping the world's poor secure access to essential medicines.

"The international system for the development, production and distribution of pharmaceutical products faces enormous challenges, but the nature of the challenges is not universal," Abbott said. "Instead, the problems facing patients, industry and regulators vary substantially by region."

For example:

The U.S. pharmaceutical sector, with the highest gross expenditure on research and development, is hampered by economic distortion and roadblocks to genuine innovation, increasingly burdening consumers and the economy as a whole.

China and India have emerged as major pharmaceutical suppliers to the world while struggling to adapt domestic regulatory systems and address local patient needs.

Africa confronts a massive disease burden, not only from HIV-AIDS, malaria and tuberculosis but also from intestinal disease, cancer, pulmonary disease, diabetes and neglected diseases such as sleeping sickness.

The Caribbean seeks to address an HIV-AIDS treatment crisis and to develop effective regional production and distribution strategies.

Latin American pharmaceutical producers increasingly confront challenges from pharmaceutical companies demanding marketing exclusivity for their drugs. At the same time, income disparities among patient groups present major access problems.

During the roundtable, the experts will seek answers to questions such as, "Are there potential common solutions to the problems confronting the global pharmaceutical sector?" "Are there models for research and development that would reduce distortions and improve the environment for innovation?" "Could regulatory efficiency be improved by increased reliance on regional and/or multilateral regulatory agencies?" "What is standing in the way of regional production facilities with capacity to supply large patient populations?" "Is there an alternative to relying on monopolies and marketing exclusivity as a means to attract research and development capital?" and "Should the United States be exporting its costly regulatory structure for pharmaceutical supply?"

For more information about topics that will be covered during the roundtable, visit www.law.fsu.edu or call Catherine Miller at (850) 644-3401.